Control and Burden of Asthma and Rhinitis

NCT01771120 | Completed

• 1 other identifier: PTDC/SAU-SAP/119192/2010
• Study Type: observational
• Target: 858
• Locations: 1 country
• Sites: 1

Brief Summary

An observational cross-sectional study will include 750 individuals of all ages, divided in 4 groups: 1) Patients with a self-reported diagnosis of asthma alone (n=150), 2) Patients with a self-reported diagnosis of rhinitis alone (n=150), 3) Patients with a self-reported diagnosis of asthma and rhinitis (n=150) and 4) Patients with no history of respiratory symptoms or diseases (n=300)

Conditions

Asthma; Rhinitis

Keywords

Asthma; Rhinitis; Control; Burden

Outcome Measures

Primary Outcomes (2)

• To validate the survey instruments used PAPS and PACS, with clinical and objective tests

  To compare the classifications of: a) asthma and/or rhinitis and b) controlled diseases obtained by the survey instruments of PAPS and PACS with the classifications obtained using clinical evaluation and diagnostic tests;

  15 months

• To compare the disease burden of the different groups of participants

  To assess the effect of diagnosis and of its control on the disease burden (quality of life, use of healthcare resources and work/school absenteeism) in the following groups: a. Diagnosis i.patients with asthma alone ii.patients with rhinitis alone iii.patients with asthma plus rhinitis iv.Individuals without respiratory symptoms b.Control i.Controlled ii.Not controlled

  15 months

Study Arms (4)

Asthma Group

Subjects will undergo diagnostic tests, medical interview and questionnaires

Other: Diagnostic tests, medical interview and questionnaires

Rhinitis Group

Subjects will undergo diagnostic tests, medical interview and questionnaires

Other: Diagnostic tests, medical interview and questionnaires

Asthma and Rhinitis Group

Subjects will undergo diagnostic tests, medical interview and questionnaires

Other: Diagnostic tests, medical interview and questionnaires

Healthy Group

Subjects will undergo diagnostic tests, medical interview and questionnaires

Other: Diagnostic tests, medical interview and questionnaires

Interventions

Diagnostic tests, medical interview and questionnaires OTHER

All patients will perform these interventions.

Asthma Group; Asthma and Rhinitis Group; Healthy Group; Rhinitis Group

Eligibility Criteria

• Age: 3 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample.

You may qualify if:

• All subjects that were included in PACS and that have expressed their willingness to participate in a clinical assessment of asthma.
• New participants that have medical diagnosis of asthma, rhinitis, or are healthy.

You may not qualify if:

• Persons who don't understand spoken portuguese. Persons who have cognitive or physical conditions thta could hamper their participation in the study.

Sponsors & Collaborators

• Universidade do Porto: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• Fundação Calouste Gulbenkian: collaborator
• Sociedade Portuguesa de Alergologia e Imunologia Clínica: collaborator
• Associação Portuguesa de Asmáticos e Alérgicos: collaborator

Study Sites (1)

Instituto CUF Porto

Porto, Porto District, 4460-188, Portugal

Location

Related Publications (14)

• Gibson PG, Simpson JL. The overlap syndrome of asthma and COPD: what are its features and how important is it? Thorax. 2009 Aug;64(8):728-35. doi: 10.1136/thx.2008.108027.

  PMID: 19638566 BACKGROUND

• Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Ait-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, Demoly P, Douagui H, Durham SR, van Wijk RG, Kalayci O, Kaliner MA, Kim YY, Kowalski ML, Kuna P, Le LT, Lemiere C, Li J, Lockey RF, Mavale-Manuel S, Meltzer EO, Mohammad Y, Mullol J, Naclerio R, O'Hehir RE, Ohta K, Ouedraogo S, Palkonen S, Papadopoulos N, Passalacqua G, Pawankar R, Popov TA, Rabe KF, Rosado-Pinto J, Scadding GK, Simons FE, Toskala E, Valovirta E, van Cauwenberge P, Wang DY, Wickman M, Yawn BP, Yorgancioglu A, Yusuf OM, Zar H, Annesi-Maesano I, Bateman ED, Ben Kheder A, Boakye DA, Bouchard J, Burney P, Busse WW, Chan-Yeung M, Chavannes NH, Chuchalin A, Dolen WK, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Keith PK, Kemp JP, Klossek JM, Larenas-Linnemann D, Lipworth B, Malo JL, Marshall GD, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Potter P, Price D, Stoloff SW, Vandenplas O, Viegi G, Williams D; World Health Organization; GA(2)LEN; AllerGen. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160. doi: 10.1111/j.1398-9995.2007.01620.x. No abstract available.

  PMID: 18331513 BACKGROUND

• National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.

  PMID: 17983880 BACKGROUND

• Bateman ED, Hurd SS, Barnes PJ, Bousquet J, Drazen JM, FitzGerald JM, Gibson P, Ohta K, O'Byrne P, Pedersen SE, Pizzichini E, Sullivan SD, Wenzel SE, Zar HJ. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008 Jan;31(1):143-78. doi: 10.1183/09031936.00138707.

  PMID: 18166595 BACKGROUND

• Chapman KR, Boulet LP, Rea RM, Franssen E. Suboptimal asthma control: prevalence, detection and consequences in general practice. Eur Respir J. 2008 Feb;31(2):320-5. doi: 10.1183/09031936.00039707. Epub 2007 Oct 24.

  PMID: 17959642 BACKGROUND

• Boulet LP, Phillips R, O'Byrne P, Becker A. Evaluation of asthma control by physicians and patients: comparison with current guidelines. Can Respir J. 2002 Nov-Dec;9(6):417-23. doi: 10.1155/2002/731804.

  PMID: 12522488 BACKGROUND

• Juniper EF, Chauhan A, Neville E, Chatterjee A, Svensson K, Mork AC, Stahl E. Clinicians tend to overestimate improvements in asthma control: an unexpected observation. Prim Care Respir J. 2004 Dec;13(4):181-4. doi: 10.1016/j.pcrj.2004.04.003.

  PMID: 16701667 BACKGROUND

• Lopes C, Fonseca J, Delgado L, Moreira A, Barros R, Moreira P, Castelo-Branco Mda G. Assessing asthma control: questionnaires and exhaled nitric oxide provide complementary information. Eur Respir J. 2008 Nov;32(5):1419-20. doi: 10.1183/09031936.00093008. No abstract available.

  PMID: 18978149 BACKGROUND

• Clatworthy J, Price D, Ryan D, Haughney J, Horne R. The value of self-report assessment of adherence, rhinitis and smoking in relation to asthma control. Prim Care Respir J. 2009 Dec;18(4):300-5. doi: 10.4104/pcrj.2009.00037.

  PMID: 19562233 BACKGROUND

• Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.

  PMID: 20816182 BACKGROUND

• Nogueira-Silva L, Martins SV, Cruz-Correia R, Azevedo LF, Morais-Almeida M, Bugalho-Almeida A, Vaz M, Costa-Pereira A, Fonseca JA. Control of allergic rhinitis and asthma test--a formal approach to the development of a measuring tool. Respir Res. 2009 Jun 17;10(1):52. doi: 10.1186/1465-9921-10-52.

  PMID: 19534774 BACKGROUND

• Fonseca JA, Nogueira-Silva L, Morais-Almeida M, Azevedo L, Sa-Sousa A, Branco-Ferreira M, Fernandes L, Bousquet J. Validation of a questionnaire (CARAT10) to assess rhinitis and asthma in patients with asthma. Allergy. 2010 Aug;65(8):1042-8. doi: 10.1111/j.1398-9995.2009.02310.x. Epub 2010 Feb 1.

  PMID: 20121755 BACKGROUND

• Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.

  PMID: 15085902 BACKGROUND

• O'Carroll RE, Smith K, Couston M, Cossar JA, Hayes PC. A comparison of the WHOQOL-100 and the WHOQOL-BREF in detecting change in quality of life following liver transplantation. Qual Life Res. 2000 Feb;9(1):121-4. doi: 10.1023/a:1008901320492.

  PMID: 10981212 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum will be retained.

MeSH Terms

Conditions

Asthma; Rhinitis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Nose Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• João A Fonseca, PhD

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 18, 2013
• Study Start: October 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 31, 2014

Record last verified: 2012-11

Locations

PT (1)